| CTRI Number |
CTRI/2020/09/027652 [Registered on: 08/09/2020] Trial Registered Prospectively |
| Last Modified On: |
31/08/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effects of nasal packing with different strengths of adrenaline in nasal surgery on the nose and body |
|
Scientific Title of Study
|
Comparison of local and systemic effects of different concentrations of adrenaline nasal packs in endoscopic sinus surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sunakshi Seigell |
| Designation |
Junior Resident |
| Affiliation |
GMCH |
| Address |
Department of ENT, head and neck surgery
Government Medical Collage hospital
sector 32
Chandigarh
Chandigarh CHANDIGARH 160030 India |
| Phone |
9845351840 |
| Fax |
|
| Email |
sunakshiseigell12@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Surinder K Singhal |
| Designation |
Associate Professor |
| Affiliation |
GMCH |
| Address |
Department of ENT, head and neck surgery
Government Medical Collage hospital
sector 32
Chandigarh
Chandigarh CHANDIGARH 160032 India |
| Phone |
9646121547 |
| Fax |
|
| Email |
singhalsks@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Surinder K Singhal |
| Designation |
Associate Professor |
| Affiliation |
GMCH |
| Address |
Department of ENT, head and neck surgery
Government Medical Collage hospital
sector 32
Chandigarh
CHANDIGARH 160032 India |
| Phone |
9646121547 |
| Fax |
|
| Email |
singhalsks@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical college and Hospital, Chandigarh |
|
|
Primary Sponsor
|
| Name |
GMCH |
| Address |
Department ofENT head and neck surgery GMCH sector 32 Chandigarh |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sunakshi Seigell |
GMCH |
Department of ENT head and neck surgery
GMCH-32 Chandigarh CHANDIGARH |
9845351840
sunakshiseigell12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee GMCH Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J329||Chronic sinusitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
blood samples for testing |
4 samples of venous blood will be drawn for assesment of level of adrenaline in plasma |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All patients undergoing endonasal sinus surgery of age between 10-60 years and of either sex will be included in this study. |
|
| ExclusionCriteria |
| Details |
Patients who have already undergone previous endoscopic sinus surgery.
Patients with uncontrolled hypertension, coronary artery disease or cerebro- vascular accident.
Patients who are younger than 10 years of age or older than 60 years of age
Patients operated under local anaesthesia.
Patients requiring infiltration of adrenaline.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Extent of adrenaline absorbed into systemic circulation after nasal packing with adrenaline soaked pledgets |
measured at 0,4,8 and 15 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| the haemodynamic parameters of the patient, with different concentrations of adrenaline used. |
at 0,4,8 and 15 minutes |
|
|
Target Sample Size
|
Total Sample Size="44" Sample Size from India="44"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/09/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Endoscopic
sinus surgery is the surgical procedure used in the management of chronic rhinosinusitis,
benign nasal tumours as well as selected malignant nasal tumours as well as in
diseases of the orbit. One of the challenges in endoscopic sinus surgery is proper
visualization of anatomical landmarks and structures, due to the high
vascularity of nose and paranasal sinuses. In addition to this, general
anaesthesia causes an overall vasodilatory effect in the body, leading to a
hyperaemic nasal mucosa. Adrenaline used either topically or by infiltration,
to achieve hemostasis, has become popular as it is inexpensive and easily
available in every hospital. Topical adrenaline in concentration of
1:1000, is the most commonly used vasoconstrictor for nasal packing currently.
It aids in achieving haemostasis and prolonging the duration of action of local
anaesthetics when added with them. By acting on both alpha and beta adrenergic
receptors of the body, adrenaline produces effects like increased
vasoconstriction (locally and systemically) and increased heart rate, cardiac
output and contractility.These physiological effects of adrenaline pose a risk
of complications like hypertension,
coronary ischemia, ventricular dysrhythmias and cerebral haemorrhage etc.
The literature
regarding systemic absorption of adrenaline and comparing different
concentrations of adrenaline and the effects it has on surgical visibility and
hemodynamic parameters is very limited. Thus, this study is being done to assess the
systemic absorption of adrenaline present in nasal packs, the haemodynamic
effects caused by it and the improvement in surgical field obtained when two
different concentrations of adrenaline are used. |